- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01630967
Effektivitetsundersøgelse af skift til en luteniserende hormon-frigivende hormon (LHRH)-antagonist fra en LHRH-agonist til behandling af progressiv kastrat-resistent prostatacancer (CRPC)
En fase II enkeltarmsundersøgelse af Degarelix hos mænd med kastratresistent prostatacancer med et stigende prostataspecifikt antigen (PSA) på trods af LHRH-agonistterapi.
Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).
Studieoversigt
Detaljeret beskrivelse
To determine the proportion of patients with castrate resistant Prostate Cancer who have a PSA decline of ≥50% from baseline PSA when switched from an LHRH agonist to an LHRH antagonist.
Undersøgelsestype
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z4E6
- British Columbia Cancer Agency
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- histologically confirmed adenocarcinoma of the prostate
- currently receiving LHRH agonist
- Anti-androgen oral therapy is permitted but will be discontinued upon enrollment
- PSA > 2 ng/ml
- rising PSA despite LHRH agonist
- patients may or may not have clinical evidence off metastases. If metastases are present, they must be asymptomatic and in bone or lymph node only
- Prior chemotherapy allowed
- ECOG performance status 0-1
Exclusion Criteria:
- Patients with a history of other active malignancies, except: adequately treated non-melanoma skin cancer, superficial bladder cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years.
- Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including: i)Significant cardiovascular condition including but not limited to: uncontrolled hypertension, unstable angina, significant congestive heart failure or myocardial infarction, deep venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6 months. ii) History of significant neurological disorder that would impair the ability to obtain consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Degarelix
Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression. |
Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
50% fall in PSA
Tidsramme: 8 weekly
|
Proportion of patients with castrate resistant prostate cancer (CRPC) who have a PSA decline of ≥50% from baseline when switched from an LHRH agonist to an LHRH antagonist |
8 weekly
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Luteinizing hormone (LH)
Tidsramme: 8 weekly
|
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
8 weekly
|
|
Follicle stimulating hormone (FSH)
Tidsramme: 8 weekly
|
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
8 weekly
|
|
Testosterone (TT)
Tidsramme: 8 weekly
|
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
8 weekly
|
|
dehydroepiandrosterone (DHEA)
Tidsramme: 8 weekly
|
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
8 weekly
|
|
dehydroepiandrosterone-sulfate (DHEA-S)
Tidsramme: 8 weekly
|
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
8 weekly
|
|
androstenedione (AED)
Tidsramme: 8 weekly
|
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
8 weekly
|
|
dihydrotestosterone (DHT)
Tidsramme: 8 weekly
|
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
8 weekly
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kim N Chi, MD, British Columbia Cancer Agency, Univeristy of British Columbia
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Genitale neoplasmer, mandlige
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Kønssygdomme, mandlige
- Prostatasygdomme
- Mandlige urogenitale sygdomme
- Prostatiske neoplasmer
- Acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl (hydroorotyl) -4-aminophenylalanyl (carbamoyl) -leucylys-prolyl-alaninamid
Andre undersøgelses-id-numre
- BCCA_Deg01
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